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Breckenridge initiates Paragraph IV ANDA litigation with Boehringer over Pradaxa generic

Breckenridge initiates Paragraph IV ANDA litigation with Boehringer over Pradaxa generic

13-03-2015

Privately-held Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application with a Paragraph…

Boehringer IngelheimBreckenridge PharmaceuticalCardio-vascularGenericsPatentsPatents & Trade marksPradaxaRegulationUSA

US FTC calls for divestitures for Impax buy of CorePharma to proceed

US FTC calls for divestitures for Impax buy of CorePharma to proceed

09-03-2015

US Federal Trade Commission imposes divestiture conditions on proposed acquisition by generic drugmaker…

CorePharmaGenericsImpax LaboratoriesMergers & AcquisitionsPerrigoPilocarpineRegulationUrsodiolUSA

Actavis confirms generic Uceris patent challenge

Actavis confirms generic Uceris patent challenge

25-02-2015

Ireland-headquartered generics major Actavis yesterday confirmed that it has filed an Abbreviated New…

ActavisCosmo TechnologiesGastro-intestinalsGenericsPatentsRegulationSalix PharmaceuticalsSantarusUcerisUSAValeant Pharmaceuticals International

Actavis receives final FDA approval for generic version of Subutex

Actavis receives final FDA approval for generic version of Subutex

22-02-2015

Ireland-headquartered generics major Actavis has received final approval from the US Food and Drug Administration…

Abbreviated New Drug ApplicationGenericsIndiviorNeurologicalRC PharmaceuticalsReckitt BenckiserRegulationSubutexUSA

Breckenridge Pharma files ANDA for generic of Sanofi’s Jevtana

12-02-2015

Privately-held US generic drugmaker Breckenridge Pharmaceutical has filed an Abbreviated New Drug Application…

Breckenridge PharmaceuticalsGenericsJevtanaOncologyPatentsRegulationSanofiUSA

Mylan confirms it is being sued by Bayer over Nexavar patent challenge

Mylan confirms it is being sued by Bayer over Nexavar patent challenge

10-02-2015

US generics drugmaker Mylan has confirmed that it has been sued by German pharma major Bayer and partner…

BayerGenericsLegalMylanNexavarOncologyOnyx PharmaceuticalsPatentsPatents & Trade marksRegulationUSA

US FDA issues another warning letter over failures at Apotex’ Indian plant

US FDA issues another warning letter over failures at Apotex’ Indian plant

09-02-2015

The US Food and Drug Administration has issued yet another warning letter to Canada-headquartered generics…

ApotexApotex Research Private LimitedGenericsIndiaProductionRegulationUSA

US FDA approves first generic of AstraZeneca’s Nexium

US FDA approves first generic of AstraZeneca’s Nexium

27-01-2015

The US Food and Drug Administration yesterday approved a generic version of Nexium (esomeprazole), Anglo-Swedish…

AstraZenecaGastro-intestinalsGenericsNexiumRegulationTeva Pharmaceutcal IndustriesUSA

Akorn files ANDA for generic Durezol

16-01-2015

US generic drugmaker Akorn has confirmed that it has filed an Abbreviated New Drug Application (ANDA)…

AkornAlconDurezolGenericsNovartisOphthalmicsPatentsRegulationUSA

US generic trade group supports compromise legislation for biosimilars

US generic trade group supports compromise legislation for biosimilars

11-12-2014

The USA's Generic Pharmaceutical Association (GPhA) has agreed to support compromise automatic substitution…

BiosimilarsGenericsLegalRegulationUSA

Supernus notified of Par Pharma ANDA filing for Trokendi XR generic

09-12-2014

US drugmaker Supernus Pharmaceuticals says that it has received a Paragraph IV Notice Letter from privately-held…

GenericsNeurologicalPar PharmaceuticalsPatentsRegulationSupernus PharmaceuticalsTrokendi XRUSA

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

FDA grants tentative approval to Mylan's two dosages of abacavir/lamivudine tablets for pediatric HIV

05-12-2014

The US Food and Drug Administration has granted tentative approval for New Drug Applications by US generic…

Abacavir Sulfate and Lamivudine TabletsAnti-viralsGenericsMylanRegulationUSA

FDA guidance for prospective ANDA sponsors

FDA guidance for prospective ANDA sponsors

04-12-2014

The US Food and Drug Administration has issued new guidance in its efforts to assist in certain circumstances…

FDAGenericsPharmaceutical sciencesRegulationUSA

Mylan confirms first-to-file patent challenge relating to Brevibloc

25-11-2014

US generic drugmaker Mylan today confirmed that it and several subsidiaries have been sued by US drugmaker…

Baxter InternationalBreviblocCardio-vascularGenericsLegalMylanPatentsRegulationUSA

Mallinckrodt questions FDA reasoning on methylphenidate ER reclassification

13-11-2014

US drugmaker Mallinckrodt says it has been informed by the Food and Drug Administration that the agency…

ConcertaGenericsJohnson & JohnsonMallinckrodtMethylphenidate Extended-Release TabletsNeurologicalRegulationUSA

FDA revokes tentative approval of Ranbaxy’s generic Nexium and Valcyte

07-11-2014

Indian generics drugmaker Ranbaxy Laboratories revealed in a Bombay Stock Exchange filing that it has…

Anti-viralsAstraZenecaGastro-intestinalsGenericsNexiumPfizerRanbaxy LaboratoriesRegulationSun PharmaceuticalUSAValcyte

New analysis of potential savings from Biosimilars in USA

New analysis of potential savings from Biosimilars in USA

04-11-2014

Introducing competing “biosimilar” versions of complex biologic drugs used to treat illnesses such…

Anti-Arthritics/RheumaticsBiosimilarsFinancialGenericsOncologyRegulationSandozUSA

Actavis challenges Quillivant XR patent

16-10-2014

Ireland-headquartered generics major Actavis confirmed that it has filed an Abbreviated New Drug Application…

ActavisGenericsLegalNeurologicalPatentsPfizerQuillivantRegulationTris PharmaUSA

FDA consent decree with Ascend Labs backed by federal judge

FDA consent decree with Ascend Labs backed by federal judge

15-10-2014

A federal judge from the US District Court for the Southern District of Ohio entered a consent decree…

Ascend LaboratoriesGenericsLegalProductionRegulationUSA

Hospira warned by FDA over Australian manufacturing facility

Hospira warned by FDA over Australian manufacturing facility

02-10-2014

USA-based injectable generic drugs specialist Hospira revealed in a filing with the US Securities and…

AustraliaGenericsHospiraProductionRegulationUSA

Actavis files ANDA for generic of Purdue's Butrans

Actavis files ANDA for generic of Purdue's Butrans

26-09-2014

Ireland-headquartered generics major Actavis has filed an Abbreviated New Drug Application with the US…

ActavisAnalgesiaBuprenorphineButransGenericsLegalPurdue PharmaRegulationUSA

Bill to increase competition for generic drugs introduced in USA

Bill to increase competition for generic drugs introduced in USA

19-09-2014

US Representatives Steve Stivers (Republican, Ohio) Peter Welch (Democrat, Vermont) on Thursday joined…

GenericsLegalPoliticsRegulationUSA

GPhA calls for feedback and dialogue on US generic legislation

GPhA calls for feedback and dialogue on US generic legislation

18-09-2014

The US Generic Pharmaceutical Association (GPhA) has identified areas in which the Generic Drug User…

GenericsGPhALegalRegulationUSA

Actavis confirms patent challenge for generic Neupro

Actavis confirms patent challenge for generic Neupro

23-08-2014

Ireland-headquartered generics major Actavis on Friday confirmed that it has filed an Abbreviated New…

ActavisGenericsLegalNeuproNeurologicalPatentsRegulationUCBUSA

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